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NCT04641481
Phase 3Interventional
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
View on ClinicalTrials.gov ↗Timeline
- Start date
- Nov 25, 2020
- Primary completion
- Jun 30, 2021
- Completion date
- Mar 1, 2022
- First posted
- Nov 23, 2020
- Last posted
- Nov 25, 2020
- Enrollment
- 25800
- Arms / groups
- 2 / —
- Source
- AACT · ingestion pipeline
Sponsors
- Bharat Biotech International LimitedLead sponsor
- IQVIACollaborator
- Indian Council of Medical ResearchCollaborator
- Vydehi Institute of Medical Sciences and Research Centre,BangaloreOverall official - principal investigator
- Vagus Super speciality hospital,BangaloreOverall official - principal investigator
- Redkar Hospital and Research Centre GoaOverall official - principal investigator
- Rahate Surgical Hospital ,NagpurOverall official - principal investigator
- Institute of Post Graduate Medical Education & ResearchOverall official - principal investigator
- Prince Aly Khan Hospital MumbaiOverall official - principal investigator
- Peoples University, Bhanpur, BhopalOverall official - principal investigator
- Nizam's Institute of Medical Sciences, Hyderabad, IndiaOverall official - principal investigator
- Lokmanya Tilak Municipal Medical CollegeOverall official - principal investigator
- King George Hospital VisakhapatnamOverall official - principal investigator
- All India Institute of Medical SciencesOverall official - principal investigator
- Government of IndiaOverall official - principal investigator
- Guru Tej Bahadur Hospital, Kanpur IndiaOverall official - principal investigator
- Guntur Medical College ,GunturOverall official - principal investigator
- Grant Government Medical College & Sir J J Group of HospitalsOverall official - principal investigator
- Gmers Medical College and Civil Hospital,AhmedabadOverall official - principal investigator
- Gauhati Medical College & Hospital AssamOverall official - principal investigator
- Mahatma Gandhi Medical CollegeOverall official - principal investigator
- ESIC Medical College and Hospital FaridabadOverall official - principal investigator
- Baba Raghav Das Medical GorakhpurOverall official - principal investigator
- Aligarh Muslim UniversityOverall official - principal investigator
Drugs studied
Indications studied
CDEK-curated fields only — the ClinicalTrials.gov results mirror (baseline measures, adverse events, participant flow) is a separate, currently-dormant pipeline; see MIGRATION_PLAN.md.